Technologist - Flu Mws/Upstream

Reference No. R2705679
Position Title: Technologist
Duration: Fixed-Term Contract, September 18, 2023-August 16, 2024 (potential for extension)
Department: Upstream & Media Washing Sterilizing Operations
Location: Toronto, Ontario
Sanofi Vaccines
Sanofi's global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.
At Sanofi, we chase the miracles of science to improve people’s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.
Major Activities of the Job:
Execution of Media, Washing, and Sterilization & Upstream activities:

• Train and ensure technical staff comply to GMP, HSE, and SOP requirements.
• Assist in review of Records, SOP, logbooks, and monitoring charts for completion and ensure accuracy of alI documents as per GMP guidelines.
• Participate in daily meetings and report findings to management.
• Participate in deviation investigations and root cause analysis.
• Coordinate with units within department (MWS, Upstream and Downstream).

Preparation of media, washing and sterilization, inoculum, analytical testing, area monitoring, maintenance, material handling, warehouse:

• Perform activities and documentation involved in MWS and Upstream including, in buffer preparation, washing and sterilizing, inoculation preparation, infectivity testing, and material handling.
• Observe in detail and report any process deficiencies, perform visual inspection of equipment for impurity and damage before and after cleaning.
• Provide guidance to technical staff on problem solving and trouble shooting.
• Perform utility sampling and environmental monitoring as required and ensure the completion as adhered to schedule.
• Perform production calculations, measurements, and release checks. Ensure each cleaning meets standards set in SOP, records, and in accordance with GMP.

Administration of data for Influenza drug substance operations:

• Complete SAP transactions in a timely, accurate manner.
• Draft, review and revise cGMP documents (SOPs/SWis, batch records, protocols, change controls, reports and other manufacturing supporting documents).
• Document and review production and monitoring activities for Influenza drug substance manufacturing
• Ensure all data is completed timely and accurately in LIMS, Master, Change Request Forms, PCS and EM system.

Health, Safety, and Environment and maintenance ofGMP environment:

• Participate in keeping the production area and office areas in a tidy, GMP manner, following 5S guideline or equivalent and supply materials as required.
• Use proper PPE when performing tasks.
• Follow HSE SOP's, identify and minimize risks, promote safety culture.
• Assist to ensure loading dock and hallways are clean and unobstructed by materials or equipment, garbage is discarded daily to designated area outside production.
• Disinfect area as required in SOP.

Process improvement, development, and preparation of trending reports for SPC analysis:

• Initiate Deviations, CCR, CAPA in Quality system as needed and assist until completion as per committed due dates.
• Modification of SOPs and BPR's for new processes in accordance with change control policies.
• Perform activities involved in IQ, OQ, and PQ for new equipment.
• Assist in writing specifications, protocols and reports related to facility, equipment, andprocess improvement of production process.
• Assist implementation of facility, equipment, and process improvement projects.

Minimum Qualifications:

• Flexibility/ Adaptability.
• Interpersonal / Teamwork.
• Minimum three (3) years College Diploma ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) plus a minimum of one (1) year of previous relevant work experience.
• Production Equipment.
• Computer.
• Stress/Time Management and Conflict Resolution.
• Mechanical Aptitude and Technical Writing.
• Communication/ Networking.
• Purification Process for viral proteins
• Preferred (4) years bachelor’s degree ( Biochemistry, Microbiology, Bioengineering, Biotechnology, Chemistry, Chemical Engineering, Pharmaceutical Sciences, other Life Science.) plus a minimum of two (2) years of previous relevant work experience.
• Current Good Manufacturing Practices (cGMPs).
• Chemistry, Microbiology, Biochemistry, Mathematics.
• Aseptic Technique.

Hours Of Work:

• Inclusive from Monday to Friday: 8:00 a.m - 4:00 p.m (subject to change)

Pursue Progress.
Discover Extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Watch our ALL IN video and check out our Diversity, Equity and Inclusion actions at sanofi.com!
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
Thank you in advance for your interest.
Only those candidates selected for interviews will be contacted.
Follow Sanofi on Twitter: @SanofiCanada and on LinkedIn: https://www.linkedin.com/company/sanofi
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.